This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.
Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy
Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms.
Patient may be otherwise treated for cystitis as per local institutional standards. Such treatments may include hydration, antiviral medications, or surgical intervention as deemed appropriate by treating physician.
Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK Virus CTL infusion
Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK Virus CTL infusion or within 3 days of planned infusion.
Thymoglobulin (ATG), campath or T cell immunosuppressive monoclonal antibodies within 30 days
Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%
Single group
BK-virus specific CTLs
Biological/VaccineHLA Matched Related Donors: BK-virus specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg). HLA Mismatched Related Donors: BK-virus specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).
Number of participants with Grade III-IV acute GVHD
Number of participants with Grade III-IV acute GVHD as assessed by CTCAE v4.0
Number of patients with undetectable BK viral load
Number of patients with undetectable BK viral load as measured by qPCR
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